Outside of Module 1, much of the documentation and data required for
regulatory submissions related to CMC activities in Tier 1 countries is
consistent, allowing pharmaceutical organizations an opportunity to
develop a single dossier to be used for all submissions throughout Tier 1
countries. Development of CMC sections of filings that are
comprehensive and appropriate to be filed in multiple countries and
regions will ultimately reduce timelines, potentially bringing products
to market more quickly. These data rich dossiers seek to provide
comprehensive data surrounding CMC, ensuring regulatory agencies in a
variety of regions have the required information in order to provide
product clearance and continued regulatory support.